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Dental Glass Ceramics Blocks (HT +2 more)

FDA 510(k)

Class II (US FDA 510(k))

510(k) K242407

by Hunan Vsmile Biotechnology Co., Ltd

Identifiers

510(k) Number
K242407 FDA 510(k)
FDA Product Code
EIH FDA 510(k)
Models / Variants
HT FDA 510(k)
LT FDA 510(k)
MT FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 872.6660 FDA 510(k)
Regulation Number
872.6660 FDA 510(k)
Advisory Committee
Dental FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Dental Glass Ceramics Blocks (HT +2 more) by Hunan Vsmile Biotechnology Co., Ltd — Class II — FDA_510K — listed in FDA 510(k) — 3 models

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

FDA Applicant
Hunan Vsmile Biotechnology Co., Ltd.

Sources (1)

  • FDA 510(k) K242407 24 fields · synced Jun 18, 2026